MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 1177-01

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

Lot number of the other used ranger drug-coated balloon, that the protective sleeve could have come from: 06451h21.

Event Description

It was reported that surgical intervention was required to remove an unretrieved device fragment.A 6x60 ranger drug-coated balloon and 6x80cm ranger drug-coated balloon were selected for use during a procedure on (b)(6) 2022.A percutaneous transluminal angioplasty (pta) procedure was performed in the right thigh.On (b)(6) 2022, the same procedure was required to be performed again due to complaints in the same leg.The intervention was unsuccessful.A femoral-crucal bypass was performed on the same day.While the p3 segment was exposed during an arteriotomy, the 13cm protective sleeve of a ranger balloon was found inside the patient, which was then explanted.The patient fully recovered.The procedure was completed.

Manufacturer Narrative

D4.Lot number: reported as 06451h21 or 01895h21.

Event Description

It was reported that surgical intervention was required to remove an unretrieved device fragment.A 6x60 ranger drug-coated balloon and 6x80cm ranger drug-coated balloon were selected for use during a procedure on (b)(6) 2022.A percutaneous transluminal angioplasty (pta) procedure was performed in the right thigh.On (b)(6) 2022, the same procedure was required to be performed again due to complaints in the same leg.The intervention was unsuccessful.A femoral-crucal bypass was performed on the same day.While the p3 segment was exposed during an arteriotomy, the 13cm protective sleeve of a ranger balloon was found inside the patient, which was then explanted.The patient fully recovered.The procedure was completed.It was further reported that the loading tool was left inside the patient.After the balloon had been used, an x-ray at the highest magnification was performed but it could not find the loading tool.The procedure performed on (b)(6) 2022 was to treat the sfa as it had become occluded again after four weeks.An arteriotomy had already been planned before the loading tool was found inside the patient.

Event Description

It was reported that surgical intervention was required to remove an unretrieved device fragment.A 6x60 ranger drug-coated balloon and 6x80cm ranger drug-coated balloon were selected for use during a procedure on (b)(6) 2022.A percutaneous transluminal angioplasty (pta) procedure was performed in the right thigh.On (b)(6) 2022, the same procedure was required to be performed again due to complaints in the same leg.The intervention was unsuccessful.A femoral-crucal bypass was performed on the same day.While the p3 segment was exposed during an arteriotomy, the 13cm protective sleeve of a ranger balloon was found inside the patient, which was then explanted.The patient fully recovered.The procedure was completed.It was further reported that the loading tool was left inside the patient.After the balloon had been used, an x-ray at the highest magnification was performed but it could not find the loading tool.The procedure performed on (b)(6) was to treat the sfa as it had become occluded again after four weeks.An arteriotomy had already been planned before the loading tool was found inside the patient.

Manufacturer Narrative

D4.Lot number: reported as 06451h21 or 01895h21.Device eval by mfr: the ranger was not received for analysis but the loading tool was received.Visual and microscopic analysis was completed.The device showed signs of use with some blood matter seen in the kinks.The device was 13 cm in length.It was round and hollow.Kinks were confirmed at 1.3 cm, 7.4 cm, 8.7 cm, and 11.1 cm, across the device.The account supplied pictures of what was explanted from the patient and the device received closely resembles the image in the pictures.The complaint was confirmed.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14580253
• MDR Text Key: 293253303
• Report Number: 2134265-2022-05897
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 01895H21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male